Back to resultsDirect Anterior Approach for Femoral Neck Fractures
Primary Purpose
Femoral Neck Fractures
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Direct anterior approach
Direct Lateral Approach
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neck Fractures focused on measuring Arthroplasty, Replacement, Hip, Orthopedic procedures
Eligibility Criteria
Inclusion Criteria:
- Dislocated femoral neck fracture
Exclusion Criteria:
- Infection around the hip (soft tissue or bone)
- Pathologic fracture
- Excessive alcohol or substance abuse that most likely will give reduced compliance
- Patients with any fractures of the long bones in the lower extremity, fracture of the spine, and/or intra-thoracic or intra-abdominal injury (i.e., multiple trauma). Because the outcomes and clinical course of patients with multiple trauma may be quite different from a non-trauma patient.
- Bedridden patients/non-walkers
Sites / Locations
- Kristiansund HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Direct anterior approach
Direct Lateral Approach
Arm Description
total hip arthroplasty with direct anterior approach
total hip arthroplasty with direct lateral approach
Outcomes
Primary Outcome Measures
Change in Time Up and Go Test (TUG)
Change in Forgotten Joint Score for hip (FJS-12)
12 questions. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score. Final score = 100 - ((sum(item01 to item12) - 12)/48*100) For the final 'Forgotten Joint Score -12' a high score indicates good outcome.
Change in Oxford Hip Score (OHS)
12 questions. Every question is scored 4 to 0 according to the selected response. Thus it is a continuous score ranging from 48-0. Each of the 12 questions on the Oxford hip score is scored in the same way with the score decreasing as the reported symptoms increase (ie. become worse). All questions are laid out similarly with response categories denoting least (or no) symptoms being to the left of the page (scoring 4) and those representing greatest severity lying on the right hand side (scoring 0).
Secondary Outcome Measures
Change in EQ-5D-5L score
5 questions. Every question is scored 1 to 5 where 5 is worse outcome. For example one profile could be' 12233' We then convert this specific health state to an index value specific for that country. The index value calculator can be downloaded from the EuroQol Office
Full Information
NCT ID
NCT03695497
First Posted
October 2, 2018
Last Updated
January 10, 2023
Sponsor
Helse Møre og Romsdal HF
Collaborators
St. Olavs Hospital, Kristiansund Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03695497
Brief Title
Direct Anterior Approach for Femoral Neck Fractures
Official Title
A Randomized Controlled Trial Comparing Direct Anterior Approach to Direct Lateral Approach in Patients Receiving a Total Hip Arthroplasty for Femoral Neck Fracture - a 1 Year Follow-up Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Møre og Romsdal HF
Collaborators
St. Olavs Hospital, Kristiansund Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective is to examine if in patients with a dislocated femoral neck fracture who receive a total hip arthroplasty, direct anterior approach will give a better result in terms of mobilization, function and pain in the first weeks and months postoperatively, than direct lateral approach.
Detailed Description
first included patient 23th November 2018
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures
Keywords
Arthroplasty, Replacement, Hip, Orthopedic procedures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Direct anterior approach
Arm Type
Experimental
Arm Description
total hip arthroplasty with direct anterior approach
Arm Title
Direct Lateral Approach
Arm Type
Experimental
Arm Description
total hip arthroplasty with direct lateral approach
Intervention Type
Procedure
Intervention Name(s)
Direct anterior approach
Other Intervention Name(s)
DAA
Intervention Description
total hip arthroplasty with DAA
Intervention Type
Procedure
Intervention Name(s)
Direct Lateral Approach
Other Intervention Name(s)
DLA
Intervention Description
total hip arthroplasty with DLA
Primary Outcome Measure Information:
Title
Change in Time Up and Go Test (TUG)
Time Frame
2,6,12 weeks, and 1 year
Title
Change in Forgotten Joint Score for hip (FJS-12)
Description
12 questions. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score. Final score = 100 - ((sum(item01 to item12) - 12)/48*100) For the final 'Forgotten Joint Score -12' a high score indicates good outcome.
Time Frame
2,6,12 weeks, and 1 year
Title
Change in Oxford Hip Score (OHS)
Description
12 questions. Every question is scored 4 to 0 according to the selected response. Thus it is a continuous score ranging from 48-0. Each of the 12 questions on the Oxford hip score is scored in the same way with the score decreasing as the reported symptoms increase (ie. become worse). All questions are laid out similarly with response categories denoting least (or no) symptoms being to the left of the page (scoring 4) and those representing greatest severity lying on the right hand side (scoring 0).
Time Frame
2,6,12 weeks, and 1 year
Secondary Outcome Measure Information:
Title
Change in EQ-5D-5L score
Description
5 questions. Every question is scored 1 to 5 where 5 is worse outcome. For example one profile could be' 12233' We then convert this specific health state to an index value specific for that country. The index value calculator can be downloaded from the EuroQol Office
Time Frame
2,6,12 weeks, and 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Dislocated femoral neck fracture
Exclusion Criteria:
Infection around the hip (soft tissue or bone)
Pathologic fracture
Excessive alcohol or substance abuse that most likely will give reduced compliance
Patients with any fractures of the long bones in the lower extremity, fracture of the spine, and/or intra-thoracic or intra-abdominal injury (i.e., multiple trauma). Because the outcomes and clinical course of patients with multiple trauma may be quite different from a non-trauma patient.
Bedridden patients/non-walkers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Magne Hoseth, md
Phone
+47 71120000
Email
john.magne.hoseth@helse-mr.no
First Name & Middle Initial & Last Name or Official Title & Degree
Otto Schnell Husby, md phd
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Øystein B Lian, md phd
Organizational Affiliation
Helse Møre og Romsdal Hospital Trust (HF), Kristiansund Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kristiansund Hospital
City
Kristiansund
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Magne Hoseth, MD
Phone
+47 71120000
Email
john.magne.hoseth@helse-mr.no
12. IPD Sharing Statement
Learn more about this trial
Direct Anterior Approach for Femoral Neck Fractures
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